D.C. Week: House Committee Advances 21st Century Cures Bill

WASHINGTON -- This week, the House Energy and Commerce Committee unanimously approved passage of the 21st Century Cures Act, which now awaits a vote from the full House. Meanwhile, a Senate committee wrestled with the long-standing problem of hospital observation stays for Medicare patients.

21st Century Cures Wins Committee Approval

On Thursday, the 21st Century Cures bill passed out of the House Energy and Commerce Committee with a vote of 51-0.

"With billions in support for our premier research and development institutions and comprehensive reform of our systems, 21st Century Cures will make a real difference in the lives of patients and their families," Diana DeGette (D-Colo.), ranking member of the Oversight and Investigations subcommittee, said in a press release.

The bill's goal is to hasten the development and delivery of new therapies by streamlining regulatory processes, investing in research, and advancing more targeted treatment options. The current bill provides $10 billion to the National Institutes of Health (NIH) over 5 years as well as additional funding for the FDA.

The bill does have its critics. Vijay Das, policy advocate at Public Citizen's Congress Watch, wrote in a press release that speeding up drug approvals would "sacrifice safety" and "put lives at risk."

Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, told MedPage Today that while the new bill would speed development of biomarkers, "[t]here's no change to the time of our review process."

Senate Committee Mulls Medicare Hospital Observation Stays

Hospital observation stays for Medicare patients can be problematic, but finding solutions is also tricky, experts told a Senate committee.

In her opening statement at a hearing Wednesday on the topic, Sen. Susan Collins (R-Maine), chair of the Senate Aging Committee, noted that CMS originally intended the observation stay "as a way to give hospital physicians more time to run tests or do lab work to decide whether the patient should be admitted to the hospital or is able enough to go home. These observation stays, which Medicare considers to be outpatient care, usually lasted between 24 and 48 hours."

However, "hospitals have been increasing use of observation stays and keeping patients in observation status longer," she continued, noting that a Brown University study published in 2012 found a 34% increase in the ratio of observation stays to inpatient admissions over a 3-year period, and also found that there was an 88% increase in the number of patients staying under observation for at least 72 hours.

GAO Disappointed in CMS's Method for Setting Physician Payment Rates

On Friday, the Government Accountability Office (GAO) published a report critiquing CMS's process for setting payment rates for physician services under Medicare.

CMS solicits input from the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), which frequently reviews the "work relative values" tied to physicians services under Medicare. These values "reflect the time and intensity needed to perform a service," according to the report.

There are obvious conflicts of interest in a medical specialty society offering its recommendations for setting such value rates. However the report found that, for the majority of services, CMS simply adopts the RUC's recommendations, and feedback from other stakeholders is scant.

According to the report, HHS backed two of the GAO's recommendations, but said rulemaking was not necessary to let the public know about "RUC-identified services." The GAO added that the recommendation is "not limited to rulemaking."

Heroin Use on the Rise, DEA Says

The threat to the nation from heroin is serious and has been increasing since 2007, the Drug Enforcement Administration (DEA) said in a report released Friday.

"Heroin is available in larger quantities, used by a larger number of people, and is causing an increasing number of overdose deaths," the DEA said in its National Heroin Threat Assessment report.

The report noted that most heroin users begin by abusing prescription opioids such as OxyContin and then move on to heroin. The threat is particularly high in the Northeast and Midwest regions, it said.

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